Adverse Effects of Statins - Myths and Reality
Abstract
Statins reduce cardiovascular mortality and morbidity as well as cardiovascular events in patients with a very high risk of cardiovascular disease (CVD) and also in subjects with high or moderate risk by reducing the levels of low-density lipoprotein cholesterol (LDL-C). Although they are considered to be drugs with a very good safety profile, because of their wide use there are many concerns that their adverse effects might compromise their proven beneficial effects. Therefore this article reviews all the data and provides an evidence- based insight what are the proven adverse effects of statins and what are the "myths" about them. The most important side effects include myopathy and rhabdomyolysis. Another side effect is increased activity of liver tests which occurs occasionally and is reversible. However, recent studies even suggest that statin therapy can improve hepatic steatosis. It is beyond any doubt that statins do slightly increase the incidence of type 2 diabetes mellitus in people with two or more components of metabolic syndrome but the cardiovascular benefits of such a treatment by far exceed this risk. Statin therapy has also been associated with some adverse renal effects, eg. acute renal failure, but recent data suggest even a possible protective effect of these drugs on renal dysfunction. Concerns that statins might increase cancer have not been proven. On the contrary, several studies have indicated a possible benefit of these drugs in patients with different types of cancer. Early concerns about cognitive dysfunction and memory loss associated with statins use could not be proven and most recent data even suggest a possible beneficial effect of statins in the prevention of dementia. Systematic reviews and clinical guidelines suggest that the cardiovascular benefits of statins by far out-weight non-cardiovascular harms in patients with cardiovascular risk.
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The use of high-intensity statins increases side effects.
“the use of high-intensity statins increases side effects”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [102]
Side effects of statins are associated with reduced therapy adherence and compliance.
“these are associated with reduced therapy adherence and compliance”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [102]
Statins are the drugs of choice in patients with high LDL-C levels and moderate to high CV risk.
“statins are the drugs of choice in patients with high LDL-C levels and moderate to high CV risk”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [102]
Use of high-intensity statins increases the risk of adverse effects and therefore worsens adherence.
“The use of high-intensity statins increases the risk of adverse effects and, therefore, worsens adherence (11,124).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [124]
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“Though intolerance to statins was considered as one of the main causes of insufficient LDL-C response to statin treatment (109), our findings add strong evidence to the current view that the cardiovascular benefits of statins far outweigh noncardiovascular harms in patients with cardiovascular risk (110).”
BackgroundTherapeutic Effects of Statins: Promising Drug for Topical and Transdermal Administration
Zahedipour, F., Hosseini, S. A., Reiner, Ž., Tedeschi-Reiner, E., Jamialahmadi, T., & Sahebkar, A. (2023) · Current Medicinal Chemistry · doi:10.2174/0929867330666230508141434 · Cited by 10 · see citing works
Self-citationZhang, Y., Lin, Y., Wu, K., Jiang, M., Li, L., & Liu, Y. (2023) · Nutrients · doi:10.3390/nu15234904 · Cited by 10 · see citing works
“Nevertheless, it is worth noting that statins often exhibit adverse effects such as hepatotoxicity, nephrotoxicity, gastrointestinal disturbances, and myotoxicity [4].”
BackgroundAbukhalil, A. D., ALYAN, M. D. M. M. Y. I. I., AbuAita, W., Al-Shami, N. A., & Naseef, H. (2022) · Patient Preference and Adherence · doi:10.2147/ppa.s376000 · Cited by 10 · see citing works
Marcuzzi, A., Piscianz, E., Loganes, C., Brumatti, L. V., Knowles, A., Bilel, S., Tommasini, A., Bortul, R., & Zweyer, M. (2015) · International Journal of Molecular Sciences · doi:10.3390/ijms17010047 · Cited by 11 · see citing works
Guo, H., Lu, Z., Zhao, B., Jiang, W., Xiong, Y., & Wang, K. (2021) · Chinese Journal of Natural Medicines · doi:10.1016/s1875-5364(21)60004-3 · Cited by 10 · see citing works
Su, Q., Liu, Y., Zhang, G., Xu, L., Wang, M., Mei, S., Garon, G., Wu, Y., Lv, Q., & Ma, C. (2023) · Advances in Therapy · doi:10.1007/s12325-023-02666-z · Cited by 9 · see citing works
“Although the cardiovascular benefits of statins have been extensively studied, current data suggest that some statins cause more adverse effects and that higher doses may be more harmful to patients [16].”
BackgroundCan we further optimize statin therapy to increase tolerability?
Ruscica, M., Reiner, Ž., & Sirtori, C. R. (2019) · Expert Opinion on Drug Discovery · doi:10.1080/17460441.2019.1615436 · Cited by 8 · see citing works
Self-citationChen, K., Chen, Y., & Huang, H. (2024) · Drugs in R&D · doi:10.1007/s40268-024-00474-6 · Cited by 7 · see citing works
“The US Food and Drug Administration (FDA) issued a warning in 2012 that statin use may increase the risk of diabetes mellitus and may cause reversible memory loss, based on case reports identified in pharmacologic clinical trials and adverse event (AE) reporting systems [17].”
BackgroundKucera, M., Marchewka, T., & Craib, A. (2021) · Spartan Medical Research Journal · doi:10.51894/001c.27627 · Cited by 7 · see citing works
Du, Z., Zhao, X. S., Sun, L., Chi, B., Ma, Z., Tian, Z., & Liu, Y. (2023) · Journal of Chromatography B · doi:10.1016/j.jchromb.2023.123889 · Cited by 7 · see citing works
Why might visit-to visit variability of lipoproteins have an effect on cardiovascular events?
Reiner, Ž. (2020) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2020.09.028 · Cited by 6 · see citing works
Self-citationMaiuolo, J., Mollace, R., Bosco, F., Scarano, F., Oppedisano, F., Nucera, S., Ruga, S., Guarnieri, L., Macrì, R., Bava, I., et al. (2023) · Agriculture · doi:10.3390/agriculture13020249 · Cited by 7 · see citing works
Cardiovascular risk management beyond statins: review of new therapies available in Italy
Capuozzo, M., Ottaiano, A., Cinque, C., Farace, S., & Ferrara, F. (2025) · The Egyptian Heart Journal · doi:10.1186/s43044-025-00660-0 · Cited by 6 · see citing works
“Commonly reported adverse effects include myalgia, fatigue, and gastrointestinal discomfort, often leading to treatment discontinuation or suboptimal adherence [7, 8].”
Pan, Y., Feng, X., Song, W. D., Zhou, X., Zhou, Z., Chen, G., Shen, T., & Zhang, X. (2023) · Drug Design Development and Therapy · doi:10.2147/dddt.s398808 · Cited by 6 · see citing works
“Some patients are reluctant to take statins at the first place due to concerns of drug side effects.(4)”
BackgroundMicroRNA-mediated Regulation of LDL Receptor: Biological and Pharmacological Implications
Keshavarz, R., Reiner, Ž., Zengin, G., Eid, A. H., & Sahebkar, A. (2023) · Current Medicinal Chemistry · doi:10.2174/0929867330666230407091652 · Cited by 6 · see citing works
Self-citationOdeleye, V., Masarweh, O., Restrepo, J., Álvarez, C. A., & Mansi, I. A. (2023) · Drug Safety · doi:10.1007/s40264-023-01347-8 · Cited by 6 · see citing works
“Statin use to target LDL-C levels is a complex decision [5].”
BackgroundYeh, L., Tang, C. Y., Yang, S., Yeh, H., Yeh, Y., Wang, Y., Chou, M., Yeh, C., & Chan, C. (2019) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph16091626 · Cited by 6 · see citing works
“However, statins have several adverse effects such as myalgia, cramps, and skeletal muscle weakness as well as myopathy and rhabdomyolysis in some cases [6,7].”
BackgroundMuscle Wasting and Treatment of Dyslipidemia in COPD: Implications for Patient Management
Bianco, A., Pagliaro, R., Schiattarella, A., Mariniello, D. F., D’Agnano, V., Cianci, R., Nigro, E., Daniele, A., Scialò, F., & Perrotta, F. (2025) · Biomedicines · doi:10.3390/biomedicines13081817 · Cited by 6 · see citing works
Zerin, F., Hoque, N., Menon, S. N., Ezewudo, E., Simon, N. P., Sooreni, S., Shahid, M. S., Jones, M., Pandey, A., Gökçe, Y., et al. (2025) · Biochemical Pharmacology · doi:10.1016/j.bcp.2025.116970 · Cited by 5 · see citing works
Farmakis, I. T., Zafeiropoulos, S., Κάρτας, Α., et al. (2019) · Acta cardiologica. Supplementum · doi:10.1080/00015385.2019.1626087 · Cited by 5 · see citing works
Vlachopoulos, C. V., Dima, I., Soulis, D., Terentes-Printzios, D. G., Skoumas, I., Aznaouridis, K. A., Solomou, E. G., Richter, D. J., & Tousoulis, D. M. (2020) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2020.04.024 · Cited by 6 · see citing works
Niu, X., Zhang, Q., Zhang, Y., et al. (2025) · Human Nutrition & Metabolism · doi:10.1016/j.hnm.2025.200300 · Cited by 4 · see citing works
Reiner, Ž. (2015) · Kardiologia Polska · doi:10.5603/kp.2015.0121 · Cited by 4 · see citing works
“potentially life-threatening rhabdomyolysis [22].”
Self-citationLiu, D., Shen, T., Ren, C., Xu, S., Zhou, L., Bai, J., Li, N., Zhao, W., & Gao, W. (2020) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2020.1786533 · Cited by 4 · see citing works
Mediterranean Diet and Neurodegenerative Diseases
Selmin, O. I., Romagnolo, A. P. G., & Romagnolo, D. F. (2016) · Springer eBooks · doi:10.1007/978-3-319-27969-5_12 · Cited by 4 · see citing works
- Authors
- Simic, I., & Reiner, Z.
- Venue
- Current Pharmaceutical Design
- Publisher
- Bentham Science Publishers Ltd.
- Published
- 2015-01-03
- Volume
- 21
- Issue
- 9
- Pages
- 1220-1226
- ISSN
- 1381-6128 (ISSN-L)
- OpenAlex
- W1980114153
- Cited by
- 126
- References
- 0
- Citations by year
- 2026: 1 · 2025: 9 · 2024: 9 · 2023: 13 · 2022: 18 · 2021: 17 · 2020: 14 · 2019: 11 · 2018: 9 · 2017: 9 · 2016: 11 · 2015: 5
- FWCI
- 8.26
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Pharmaceutical Design (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- statins, adverse drug reactions, myopathy, rhabdomyolysis, hepatotoxicity, hepatic steatosis, type 2 diabetes, metabolic syndrome, renal effects, acute kidney injury, cancer risk, cognitive impairment, dementia prevention, cardiovascular risk, LDL cholesterol lowering
- MeSH terms
- Humans, Muscular Diseases, Rhabdomyolysis, Risk Assessment, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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